Safety and Efficacy Study of a Non-antibiotic Treatment for the Eradication of Helicobacter Pylori

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At present, triple therapy is recommended by various guidelines for the treatment of Helicobacter pylori (H.pylori) infection. Recent studies have shown increasing resistance of H.pylori to commonly used antibiotics used in triple therapy. This study explores a non-antibiotic treatment regime for H.pylori that uses lauric acid as the primary anti-microbial agent. The study hypothesis is that Lauric acid works synergistically with omeprazole following administration of a mucolytic agent to kill H.pylori topically in the stomach.

Absence of Significant Gastric Abnormality Post-treatment (Initial Phase) [ Time Frame: up to 14 days of treatment ]

Gastroscopy pre- and post-treatment will be performed in the Initial Phase (20 participants), with the goal of excluding significant gastric abnormality at baseline and after treatment (e.g. gastric ulceration arising following the treatment).

Secondary Outcome Measures :

Assessment of Adverse Events (AE) [ Time Frame: AE commencing within 30 days of initiation of treatment, followed until resolution ]

Adverse event data will be collected in response to neutral questioning.

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Ages Eligible for Study:

21 Years to 70 Years (Adult, Older Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Informed Consent prior to any study procedure

Age at least 21 years and up to 70 years

If female of childbearing potential who is sexually active, agrees to use acceptable methods of birth control throughout the study. Acceptable methods of birth control are: hormonal contraceptives (birth control pills), intrauterine device (IUD), diaphragm with spermicide, condom, vasectomy.

Additional Inclusion Criteria for Initial Phase only

Healthy volunteers - can have gastrointestinal or other symptoms if these do not require medical treatment and are considered by the investigator to be clinically minor and irrelevant to the conduct of the study.

Positive laboratory serology for H.pylori

Positive Urea Breath Test for H.pylori

Willing to undergo two gastroscopy procedures

Additional Inclusion Criteria for Secondary Phase only

Either healthy volunteers or patients attending gastroenterology outpatient clinic - can have gastrointestinal or other symptoms if these are considered by the investigator to be clinically minor or irrelevant to the conduct of the study.

Positive diagnosis of current H.pylori infection, as diagnosed by positive Urea Breath Test and at least one of the following: 1) Positive laboratory serology for H.pylori, 2) known positive Campylobacter-like organism (CLO) test or H.pylori culture from a gastroscopy performed in the 1 year prior to Screening.

Exclusion Criteria:

Pregnant or breast feeding.

Clinically significant gastric disease, in the opinion of the investigator.

Significant disease or disorder on general medical examination, in the opinion of the investigator (general, respiratory, cardiovascular, renal, hepatic, neurological, bleeding tendency etc).

Regular or intermittent use of antibiotics, non-steroidal anti-inflammatory drugs (NSAIDs), anticoagulants or antiplatelet medications is expected during the trial period.

Cessation of proton pump inhibitor or H2-blocker therapy for 2 weeks prior to Urea Breath Test is likely to not be in the best interests of the participant.